Biopsy samples have been obtained in a variety of ways with various medical devices. An example biopsy device is disclosed in U.S. Pat. No. 8,864,682, entitled “Clutch and Valving System for Tetherless Biopsy Device”, issued Oct. 21, 2014.
Biopsy marker clips have been deployed in a variety of ways with various medical devices. An example marker clip deployment device is disclosed in U.S. Pub. No. 2013/0237912, entitled “Biopsy Marker Delivery Device”, published Sep. 12, 2013. Another example marker clip deployment device is disclosed in U.S. Pat. No. 6,261,302, entitled “Applier for Implantable Surgical Marker”, issued Jul. 17, 2001.
A typical biopsy procedure is to use a tetherless device such as described in U.S. Pat. No. 8,864,682. A cannula tube would be installed over the device needle. The cannula tube/device needle would be inserted into the patient and the tissue sample obtained. The cannula would be left in place when the device needle is removed. Keeping the cannula from moving during device needle removal or after is an important procedure task.
A typical marker delivery procedure would then follow using a device such as described in US2013/0237912. The goal of the clip marker deployment is to place the clip marker as accurately as possible to the site where the tissue sample was removed. The deployment device would be inserted into the patient though the cannula. Again, keeping the cannula from moving during delivery device insertion is an important procedure task. The amount of insertion depth is another important procedure task.
The biopsy device (which has been removed from the cannula) obtained the tissue sample from the needle window at a specific angular orientation relative to the axis of the cannula. For accurate clip marker placement, it is important for the deployment device window be along the same angular orientation as the biopsy needle window during the moment of tissue sample. Rotating the deployment device within the cannula to align with the biopsy device needle window is another important procedure task.
The clip marker is then deployed with a manual pushing of a knob on the marker delivery device.
If the lesion is small, or has been completely removed during the biopsy procedure, it is critical to keep the ultrasound probe localized to the area of the procedure during the marker clip placement. This often requires two people, as one hand is required to hold the ultrasound transducer so as to not lose the procedure site, a second hand is required to hold the cannula, and a third hand is required to remove the device needle. A device that allows this step to be performed by one person would be advantageous.
Integration of the biopsy device with marker clip deployment has been disclosed in a variety of ways with various medical devices. An example integrated deployment device is disclosed in U.S. Pat. No. 8,728,003, entitled “Single Insertion, Multiple Sample Biopsy Device With Integrated Markers”, issued May 20, 2014. Another example integrated deployment device is disclosed in U.S. Pat. No. 8,167,817, entitled “Methods And Devices For Removing Tissue From A Patient And Placing A Marker In The Patient”, issued May 1, 2012.
A limitation of these integrated deployment devices is that the marker clip does not include a pledget. The pledget surrounds the marker clip and facilitates the implatation of the marker clip to the surrounding tissue. Another limitation is the use of a low force deployment method such as springs. A high force method ensures reliable marker clip deployment. Another limitation is re-direction of the marker clip motion such as side loading into the needle axis. Keeping the motion of the marker clip in a straight line until exit from the needle window ensures reliable deployment.
The disclosure of each of the above-cited U.S. Patents, U.S. patent application Publications, U.S. Provisional Patent Applications, and U.S. Non-Provisional patent application is incorporated by reference herein.